A Trial of Single- and Multiple-doses of Aripiprazole in Adult Subjects With Schizophrenia or Bipolar I Disorder

NCT ID: NCT03854409

Last Updated: 2020-09-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-31
• Study Completion Date: 2020-02-20

Brief Summary

The primary objective of this trial is to evaluate the pharmacokinetics (PK) of aripiprazole long-acting injectable (LAI) (420 mg) following deltoid or gluteal muscle administration in adult subjects with schizophrenia or bipolar I disorder.

Conditions

Schizophrenia; Bipolar I Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Part A - Deltoid Site: Single Dose Group

Participants will receive a single dose of aripiprazole LAI.

Group Type: EXPERIMENTAL

Aripiprazole

Intervention Type: DRUG

Injection.

Part A - Gluteal Site: Single Dose Group

Participants will receive a single dose of aripiprazole LAI.

Group Type: EXPERIMENTAL

Aripiprazole

Intervention Type: DRUG

Injection.

Part A - Deltoid Site: Multiple Dose Group

Participants will receive five injections of aripiprazole LAI, administered at monthly intervals.

Group Type: EXPERIMENTAL

Aripiprazole

Intervention Type: DRUG

Injection.

Part A - Gluteal Site: Multiple Dose Group

Participants will receive five injections of aripiprazole LAI, administered at monthly intervals.

Group Type: EXPERIMENTAL

Aripiprazole

Intervention Type: DRUG

Injection.

Part B - Gluteal Site: Group 1 (X)

Participants will receive a single dose of aripiprazole LAI.

Group Type: EXPERIMENTAL

Aripiprazole

Intervention Type: DRUG

Injection.

Part B - Gluteal Site: Group 1 (Y)

Participants will receive a single dose of aripiprazole LAI.

Group Type: EXPERIMENTAL

Aripiprazole

Intervention Type: DRUG

Injection.

Part B - Gluteal Site: Group 2

Participants will receive a single dose of aripiprazole LAI.

Group Type: EXPERIMENTAL

Aripiprazole

Intervention Type: DRUG

Injection.

Interventions

Aripiprazole

Injection.

Intervention Type: DRUG

Other Intervention Names

(OPC-14597)

Eligibility Criteria

Inclusion Criteria

• Male and female subjects between 18 and 64 years of age, inclusive.
• Body mass index of 18 to 35 kg/m2, inclusive.
• A current diagnosis of schizophrenia or a current diagnosis of bipolar I disorder as defined by DSM-5 criteria.
• Prior history of tolerating aripiprazole per investigator's judgment.

Exclusion Criteria

• Subjects who have met DSM-5 criteria for substance dependence within the past 180 days
• Use of any psychotropic medications other than their current non-aripiprazole antipsychotic or mood stabilizer(s) medication or subjects who use more than one antipsychotic or mood stabilizer(s) medication at screening.
• Subjects may not receive varenicline beyond screening.
• Use of any prescription medication not specifically approved by the medical monitor.
• Females who are pregnant or lactating. A negative serum pregnancy test must be confirmed prior to the first dose of IMP for all female subjects.
• Subjects who had participated in any clinical trial involving a psychotropic medication within 1 month prior to enrollment; subjects who had participated in a previous aripiprazole LAI trial within the last 1 year (ie, enrolled but did not receive aripiprazole LAI); or who had previously enrolled and received IMP in an aripiprazole LAI clinical trial.
• Any major surgery within 30 days prior to enrollment or scheduled/elective surgery during the trial.
• Subjects currently in an acute relapse of schizophrenia.
• Subjects with a current DSM-5 diagnosis other than schizophrenia or bipolar I disorder
• Electroconvulsive therapy must not be conducted within 2 months prior to administration of the IMP
• Subjects with a history of neuroleptic malignant syndrome or clinically significant tardive dyskinesia as assessed by the investigator.
• History of or current hepatitis or acquired immunodeficiency syndrome or carriers of HBsAg, anti-HCV, and/or HIV antibodies.
• History of any significant drug allergy or known or suspected hypersensitivity, in particular to aripiprazole or other quinolinones.
• Subjects deemed intolerant of receiving injections.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

PRA Health Sciences

INDUSTRY

Sponsor Role: collaborator

H. Lundbeck A/S

INDUSTRY

Sponsor Role: collaborator

Otsuka Pharmaceutical Development & Commercialization, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Woodland International Research Group

Little Rock, Arkansas, United States

Collaborative Neuroscience Network

Garden Grove, California, United States

Hassman Research Institute

Berlin, New Jersey, United States

Community Clinical Research

Austin, Texas, United States

Countries

United States

Other Identifiers

031-201-00279

Identifier Type: -

Identifier Source: org_study_id